Quality Systems Specialist
Oxford, UK, Hybrid
Oxford Nanopore Technologies (ONT) develops and manufactures innovative nanopore-based sequencing technologies for global research, biopharma, and IVD markets. Operating under ISO 13485 and ISO 9001 quality management systems, ONT ensures compliance with global regulatory requirements.
A sub-team of the QARA department, the Quality Systems team is responsible for ensuring that systems and processes are integrated across all departments and projects, promoting consistency and continuous improvement across the firm.
The Quality Assurance Specialist is responsible for the review and approval of key quality system records and activities within the Quality Management System (QMS), ensuring compliance with internal procedures and applicable regulatory standards (including ISO 13485 and ISO 9001).
In addition, the role is accountable for driving end-user adoption and effective utilisation of the company's electronic QMS (eQMS), and for increasing quality awareness across the organisation. The post holder will lead initiatives to improve engagement, understanding, and consistency in the application of quality processes.
The role acts as a quality gatekeeper, QMS adoption lead, and quality culture champion, providing both operational oversight and organisational influence.
Quality Event Review and Approval
- Review and approve Change Control and Deviation requests, Nonconformance reports, CAPA records
- Critically assess Root Cause Analysis, Risk Assessments, proposed corrective and preventive actions
- Ensure timely progression and closure of quality events
Escalate significant quality or compliance risks
eQMS Adoption and User Engagement
- Act as the lead for end-user adoption of the eQMS (e.g. MasterControl)
- Develop and maintain training materials, user guides and support resources
- Deliver or coordinate training to drive effective system use
Design, initiate, and manage user feedback mechanisms (e.g. surveys)
Quality Awareness and Culture Development
- Lead initiatives to increase quality awareness across the organisation
- Plan and organise Quality Week and engagement events
- Develop and streamline GxP training materials to improve accessibility and effectiveness
Draft and deliver QA communications, updates and newsletters
QA SharePoint and Knowledge Management
- Own and manage the QA SharePoint site as a central hub for quality communication and resources
- Maintain and update content for organisation-wide audiences (e.g. newsletters, announcements, awareness content) and internal QA users (e.g. quality records, guidance, process resources)
- Ensure content is accurate, structured, accessible, and kept up to date
Continually improve site usability and effectiveness as a communication and knowledge platform
- Identify and report any quality or compliance concerns
- Be aware of and comply with the Quality Manual, Quality Management System, Quality Policy, Quality Goals and applicable regulations as they apply to this job type/position
- Provide QA guidance and constructive challenge to ensure compliance
- Influence behaviours and promote best practices across the organisation
- Provide expert guidance to stakeholders on QMS processes
Any other duties as might be required within the remit and responsibilities of the post
About You
Qualifications/ Education:
- B.Sc. Degree in a relevant STEM discipline or equivalent relevant experience
ISO 9001 or ISO 13485 Internal auditor training is desirable
Experience:
At least 3 years experience in a Quality Assurance role within a regulated environment
Experience reviewing and approving Change Controls, CAPAs, Deviations, Nonconformances
Experience developing training content and driving QMS adoption
Experience managing or contributing to internal communications (e.g. newsletters, SharePoint, awareness initiatives)
Knowledge/Skills/Abilities:
Ability to critically assess investigations and challenge effectively
Strong written communication skills (training, newsletters, user content)
Ability to influence stakeholders and drive behavioural change
Strong organisational and information management skills
Analytical mindset (e.g. using feedback to improve systems and engagement)
Attitude/Other Requirements:
Proactive and self-motivated
Positive and collaborative team attitude
Ability to prioritise tasks and manage multiple activities
Ability to work independently in a fast-paced and changeable environment
Join us and help ensure the quality and compliance of technologies transforming genomics and diagnostics globally.
Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.
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Oxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.
